Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for supporting the product development process, submissions and regulatory compliance.
Key Responsibilities
* Act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review.
* Assist with departmental policy and procedure implementation.
* Generate and implement regulatory strategies for new and modified medical devices.
Required Skills and Qualifications
To be successful in this role, you will need:
* A Level 8 Bachelor's Degree in STEM (regulatory affairs or relevant discipline).
* A minimum of 7 years' experience in Regulatory Affairs or a related discipline within the medical device industry.
* Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards.
Benefits
As a member of our team, you can expect:
* Competitive salary and benefits package.
* Ongoing training and development opportunities.
* The chance to work on challenging projects and contribute to the success of our organization.
About Us
We are a global leader in medical science, committed to solving the challenges that matter most – united by a deep caring for human life.